It is now generally acknowledged that indwelling catherization in medical, surgical, gynecological, urological and other patients leads to serious infection of the urogenital tract. The process of indwelling catherization is performed in approximately 10 to 15 percent of hospitalized patients. Despite the use of the most careful aseptic techniques undertaken while the catheter is in the patient, approximately fifty percent of the patients develop an infection when a catheter is in place for twenty-four hours or longer. This is harmful to the patients because they are subjected to the risk of cystitis, acute pyelonephrititis and life-threatening septicemia, which carries a risk of mortality, as reported in Arch. Internal Med., Vol. 110, pp. 703-11, (1962); Antimicrob. Agents Chemother., pp 617-23, (1963); and Lancet, Vol. 1, pp. 310-12, (1960).
The occurrence of the above-mentioned infection is encouraged by many circumstances. These circumstances include prolonged use of indwelling Foley catheters often accompanied by the absence of a sterile insertion and maintenance techniques, and by having the catheter connected to a clean, but not sterile drainage collection container placed in the immediate vicinity of the patient's bed. These and other circumstances that predispose a patient to infection are reported in Urinary Tract Infection And Its Management, edited by Kaye, D., Chapter 15, "Care of the Indwelling Catheter," pp. 256-66, (1972), published by the C. V. Mosby Company, St. Louis, Mo.; and in "Factors Predisposing To Bacteriuria During Indwelling Urethral Catheterization," New Eng. J. Med., Vol. 291, pp. 215-23, (1974).
Attempts have been made by the prior art to reduce the incidence of catheter acquired infections, to reduce the presence of unwanted organisms in drainage containers, but these attempts have not met with general acceptance. For example, one attempt consists in systemic chemoprophylaxis achieved by orally administering an antibiotic such as chloramphenicol, penicillin or streptomycin. This attempt, however, affords no significant protection against the acquisition of infection after indwelling catherization, as reported in Arch. Internal Med., Vol. 110, pp. 703-11, (1962); Acta Chiv. Scand., Vol. 118, pp. 45-52, (1959); and Dis. Mon., pp. 1-36, (Sep. 1960).
The attempts made by the prior art for preventing or eliminating unwanted organisms also include adding a biocide to the inside of a drainage container, or placing a device inside the container wherein the device releases a biocide. For example, formalin is added to the fluid collection container for controlling, that is, killing pathogens. This method, however, does not enjoy general use because there is a risk of siphoning formalin into the urinary tract, as reported in British Med. J., Vol. 2, pp 4233-25, (1964). In U.S. Pat. No. 4,233,263 the patentee Shaeffer disclosed adding 3% hydrogen peroxide solution to a urine bag for reducing the risk of urinary tract infection. This method is inherently subjected to poor results because of a lack of compliance. That is, each time urine is drained from the urinary drainage bag the hydrogen peroxide is drained and it must be reintroduced into the bag every 8 hours. This requires mixing and agitation, and it is often accompanied by spilling of the solution. Also, hydrogen peroxide loses its strength over time. In U.S. Pat. Nos. 4,193,403 and 4,241,733 Langston et al disclose a device inside a urinary drainage bag. The device contains paraformaldehyde that depolymerizes to formaldehyde in the presence of moisture inside the drainage bag. While formaldehyde is an antimicrobial, it is not used because it may be injurious to an animal host. In World Intellectual Property Organization Appln. Ser. No. 84/04036 Stupar et al disclosed a urine bag provided with gas generating compounds that are activated by proximity to urine to give a gaseous halogen antimicrobial. This too has not enjoyed acceptance because gaseous halogen compounds are injurious to the mucosal tissues of the unitary tract.
It will be appreciated by those versed in the urinary drainage art that, in view of the above presentation, a critical need exists for a novel and unique means for introducing a biocidal agent into a urinary drainage system. The need exists for an acceptable and workable means for introducing a biocide into a urinary drainage system and the need also exists for overcoming the difficulties associated with the prior art use of an internal biocide and an internal delivery device. It will be further appreciated that a pressing need exists for a biocidal delivery means that is not introduced into the urinary container, but can provide a biocidal agent from an external delivery source in contact with the outside of the drainage container.